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NCT00315263 Clinical Trial

Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology

Respiratory Failure Clinical Trial

Official title:
Genomics, SNPs, and Clinical Neonatology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00315263
Other study ID # 01.3965
Secondary ID
Status Completed
Phase N/A
First received April 14, 2006
Last updated August 25, 2011
Start date April 2006
Est. completion date July 2011

Study information
Verified date August 2011
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF).

Description:

This genetic predisposition study does not involve investigational drugs, devices, or treatments. Our broad goal is to identify genomic factors, which contribute to the development or exacerbation of common and critical illnesses that affect preterm and near-term infants. We seek to accomplish this goal in the following ways:

- First: to test candidate gene DNA variations and link already identified single nucleotide polymorphisms (SNPs) producing functional alterations to the risk of clinically important disorders.

- Second: to utilize a whole-genomic approach to identify SNPs not previously linked to the risk of development or progression of neonatal disorders.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date July 2011
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Less than 34 weeks gestation and less than 1500 g at birth

- Greater than or equal to 36 weeks gestation and either with hypoxic respiratory failure or with mild respiratory distress never requiring assisted ventilation

Exclusion Criteria:

- Life threatening anomalies of any organ system (e.g., cardiac, thoracic, lethal, or non-lethal chromosomal abnormalities)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Mercy Hospitals and Clinics Kansas City Missouri
United States Truman Medical Center Kansas City Missouri

Sponsors (2)
Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

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